FDA Adverse Event
Injury
Summary report: N
OBTRYX SYSTEM
MDR report key: 4346459
·
Received December 19, 2014
Report
- Report Number
- 3005099803-2014-04044
- Event Type
- Injury
- Date Received
- December 19, 2014
- Report Date
- October 31, 2014
- Product Code
- OTN
- PMA / PMN Number
- K040787
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ (B)(4) FOR PRODUCT CODE OTN. (B)(6).
Description of Event or Problem · 1
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ (B)(4) FOR PRODUCT CODE OTN. (B)(4).SUBMISSIONS FOR PRODUCT CODES OTP AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2014-04042 AND 3005099803-2014-04043.
Description of Event or Problem · 1
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - (B)(4) FOR PRODUCT CODE OTN. (B)(6). SUBMISSIONS FOR PRODUCT CODES OTP AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2014-04042 AND 3005099803-2014-04043.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 835533 | OBTRYX SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR | OTN | M0068505000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |